Evicenter
P&T meetings

SL1009 (sodium dichloroacetate)

Pyruvate dehydrogenase complex deficiency

Manufacturer
Saol Therapeutics
Regulatory submission
NDA resubmitted June 2026
Launch
Not announced
Last updated
78 sources

Product information and disease descriptionProduct descriptionProduct informationDosing and administration

Dosage

4 evidence topics · 4 sources

Genotype-directed dosing in the phase 3 trial

““fast” (12.5mg/kg/12h) or “slow” (6.25mg/kg/12h) DCA metabolizer” (opens the source at this quote in a new tab)

Dose-determining genetic test

“The test identifies each patient's GSTZ1 genotype to provide individualized dosing intended to reduce adverse events, such as peripheral neuropathy.” (opens the source at this quote in a new tab)

Clinical pharmacogenetic test validation

“The clinical genetic test for GSTZ1 was developed and validated at our CLIA-certified Clinical Laboratory.” (opens the source at this quote in a new tab)

Companion diagnostic: planned submission pathway

“will be filing a 510K for the dose-determining genetic test” (opens the source at this quote in a new tab)